FDA Publishes Court-Ordered Cigarette Graphic Warning Proposed Rule, Industry Challenge Expected

On August 15, 2019, the U.S. Food and Drug Administration (FDA or the Agency) published a court-ordered proposed rule that, if finalized, would mandate graphic health warnings for cigarette packaging and advertisements to “promote greater public understanding of the negative health consequences of smoking.”  

FDA’s proposed warnings are undeniably graphic and feature “photo-realistic” images of “some of the lesser-known, but serious health risks of cigarette smoking,” including secondary harm to children, fatal lung disease in non-smokers, head and neck cancer, reduction of blood flow (which can lead to erectile dysfunction or require digit or limb amputation), and type 2 diabetes.  If finalized, the proposed rule would require the images to occupy the top 50 percent of both the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements. Companies will have fifteen months after a final rule is issued to comply with these proposed requirements.

This proposal represents FDA’s latest effort in cigarette packaging reform since Congress required the Agency to take action after it passed the 2009 Family Smoking Prevention and Tobacco Control Act (the Act).  In June 2011, FDA first issued a final rule requiring graphic warnings for cigarette packaging and advertisements; however, this rule was quickly challenged by the tobacco industry under First Amendment grounds and was overturned by the U.S. Court of Appeals for the District of Columbia (D.C. Circuit) in R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Administration, 696 F.3d 1205 (D.C. Cir. 2012).  Applying the intermediate scrutiny standard articulated in Central Hudson Gas & Elec. Co. v. Public Serv. Comm. of N.Y., 447 U.S. 557 (1980), the D.C. Circuit determined that FDA did not put forth substantial evidence that its graphic warnings would “directly” reduce smoking by a “material degree,” so FDA could not compel tobacco companies to use its graphic warnings on cigarette labeling.

But, in October 2016, several public health and medical groups filed a lawsuit against FDA again, arguing that the Agency unlawfully delayed issuing a final rule requiring warnings for cigarette packaging and advertisements in violation of the Act.  In March 2019, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts ordered FDA to publish a proposed rule by August 2019 and a final rule by March 2020.  It seems likely that the tobacco industry will again challenge FDA’s attempt to require graphic warnings.  This time, and seemingly in anticipation of such a challenge, FDA has made a concerted effort to support its proposed warnings through a “comprehensive, science-based research and development process,” citing over 200 studies in the proposed rule.  Even still, proving that the proposed graphic warnings will be effective in reducing smoking will not be easy.  Yet another challenge for FDA will be meeting the court-ordered deadline of issuing a final rule by March 2020, which leaves only five months for the Agency to review and respond to public comments on the proposed rule.

Interested stakeholders can submit comments to FDA beginning today, August 16, 2019, via www.regulations.gov (Docket No. FDA-2019-N-3065). The comment period closes on October 15, 2019. If you have any questions regarding FDA’s proposal or would like assistance preparing and filing comments with the Agency, please contact the authors or the attorney at the firm with whom you are regularly in contact.